Wednesday, April 24, 2013

APhA- House hearing: FDA seeks stronger authority over compounding pharmacies: Republicans not so sure new legislation needed; Democrats’ request for IACP testimony rejected by Republicans

At today’s hearing held by the House Energy & Commerce Subcommittee on Oversight and Investigations, FDA Commissioner Margaret A. Hamburg, MD, repeatedly argued for new legislative authority over the highest-risk compounding pharmacies even as questions posed by the Republican majority conveyed skepticism about the need for new legislation.

The 3-hour investigative hearing, A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented, featured testimony under oath primarily by one witness—Hamburg—as well as a lawyer at FDA. Throughout the hearing, Hamburg often responded that she could not answer questions because of the ongoing criminal investigation.

Hamburg’s introductory testimony barely dipped into her written testimony, which referred to the 1997 law that added section 503A to the Food, Drug, and Cosmetic Act, and to subsequent conflicting court decisions interpreting the law differently for different parts of the country.
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